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FDA announces the approval of a treatment for patients with non-radiographic axial spondyloarthritis, a type of inflammatory arthritis.


FDA recently approved Cimzia (certolizumab pegol) for the use of adults with non-radiographic axial spondyloarthritis (nr-axSpA), a form of inflammatory arthritis [1]. The medicine will be available in the form of an injection. Cimzia is the first approved treatment for nr-axSpA. It was initially approved in 2007 and since then has had wide applications in treating patients with Crohn’s disease, active ankylosing spondylitis (AS), moderate-to-severe rheumatoid arthritis and plaque psoriasis who are candidates for systemic therapy or phototherapy. The approval was given to UCB.

Difference between Rheumatoid-Arthritis and Osteoarthritis

From Visually.

 

Non-radiographic spondyloarthritis (nr-axSpA) is a type of inflammatory arthritis that causes inflammation mainly in the spine. Since no visible changes are observed in X-rays, this condition is referred to as non-radiographic. Cimzia is prescription injection called a Tumor Necrosis Factor (TNF) blocker [2]. The drug efficacy was determined by using data from studies that included a randomized clinical trial with 317 adult patients with nr-axSpA. They have a visible sign of inflammation as also indicated by an elevated level of CRP (C-reactive protein) and/or inflammation of the sacroiliac joints on MRI. An improvement on the Ankylosing Spondylitis Disease Activity score was used as a measurement in the trial. It is a composite scoring system that determines the activity from patient-reported outcomes and CRP levels. A significant response was obtained for patients on Cimzia when compared to those on placebo. The safety profile was also consistent with the overall known safety profile of Cimzia. But because the medication can lower the ability of one’s immune system to fight infection, the prescribing information comes with a Boxed warning that warns patients and healthcare providers about the serious risk of infections leading to hospitalization which could be fatal at times. Some other associated infections include, tuberculosis (TB), bacterial sepsis, histoplasmosis (invasive fungal infection affecting the lungs) etc. Healthcare professionals have been requested to perform tests for latent TB. If found positive, one should receive a treatment for TB prior to using Cimzia. The patients should be continuously monitored for the development of TB even if the initial tests were negative. Since Cimzia is a TNF blocker, there are some added observations that need to be maintained during the course of the treatment. There are cases where children and adolescents have developed lymphoma and other malignancies while on similar TNF-blockers. It has thus been included in the boxed warnings. Patients must have the access to a “patient medication guide” which mentions, in details, the risks and benefits of the use of Cimzia.

“Today’s approval of Cimzia fulfills an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there has been no FDA-approved treatments until now,” said Nikolay Nikolov, M.D., associate director for rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

 

 

FDA announces the approval of Mavenclad (cladribine) oral tablets for multiple sclerosis.


FDA recently announced the approval of an oral treatment for patients with relapsing forms of multiple sclerosis (MS) in adults, to include active secondary progressive disease and relapsing-remitting disease [3]. The use of Mavenclad has been restricted to patients who do not respond adequately or are unable to tolerate any other medicines for the treatment of multiple sclerosis. It is not recommended for clinically isolated syndrome. The approval was given to EMD Serono, Inc.

 

The early symptoms of multiple sclerosis become visible between the ages 20 and 40 and is the most common cause for neurological disability in this population. MS is more prevalent in women than in men. It is a chronic, neurological, autoimmune disease that affects the central nervous system which disrupts the communication between the brain and other parts of the body. Many people with MS undergo a relapsing-remitting course. In these courses, relapse phases are often followed by remission or recovery phases. In most cases these remissions may not be complete as a result of which patients often have some residual disability, which may worsen over time. Sometimes the patients may undergo secondary progressive multiple sclerosis (SPMS). Active SPMS is a relapsing form of MS and some patients may continue to experience it in the first few years. Usually the drugs available to treat relapsing forms of MS are sufficient to treat those with active SPMS. The approval of Mavenclad was based on data obtained from a clinical trial in 1326 patients with relapsing forms of MS, who had at least one relapse in the last 12 months. When compared to placebo, there was a significant reduction in the number of relapses in patients treated with Mavenclad. It also reduced the progression of disability when compared to placebo. The only and most common adverse effects associated with the clinical trials involving Mavenclad were headache, decreased lymphocyte counts and upper respiratory tract infection. A few points must be taken into consideration by the patients and healthcare professionals while using Mavenclad. It comes with Boxed warning for an increased risk of fetal harm and malignancy. Those with current malignancy should not be prescribed Mavenclad. An individual-based treatment should be followed for patients with prior or increased risk of malignancy. Healthcare professionals should carry out a standard screening for cancer in patients using Mavenclad. Typically, the drug should not be administered to pregnant women and should be stopped if a patient becomes pregnant. It should not be used in case of men and women of reproductive potential who do not plan to use contraception during the treatment and for six months after the treatment as there might be a potential of fetal harm. There could be a decrease in lymphocyte counts, hence a constant monitoring is required. There could be an increased risk of infections and care should be taken to detect it and treat it. Mavenclad may cause hematologic toxicity and bone marrow suspension. It could cause liver injury and following significant injury, the medication should be interrupted or discontinued. Due to the above-mentioned factors, Mavenclad must be accompanied with a “patient medication guide” describing the important information about the drug, its safety and risks.

“We are committed to supporting the development of safe and effective treatments for patients with multiple sclerosis,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “The approval of Mavenclad represents an additional option for patients who have tried another treatment without success.”

 

FDA approves Jatenzo, an oral testosterone capsule, to treat patients with certain forms of hypogonadism.


FDA recently approved the use of an oral testosterone capsule, Jatenzo, to treat men with certain forms of hypogonadism [4]. Genetic disorders like Klinefelter syndrome or pituitary gland damaging tumors could lead to a lower testosterone level in such patients. Jatenzo is not to be used for decreasing levels of testosterone due to age, even if the symptoms are similar to those related to low hormone levels. In the above-mentioned case, the benefits of the medications do not surpass the risks associated with it. The approval was given to Clarus Therapeutics.

The approval was based on data from a four-month clinical trial. The trial involved 166 men with hypogonadism. A dose of 237 mg of Jatenzo was given twice per day. This dose was either reduced or increased to a maximum of 396 mg twice per day based on the levels of testosterone. The primary endpoint was to determine if such patients were able to reach the normal range. It was observed that about 87 percent of those treated with Jatenzo, were able to reach an average level between the normal range. The most common adverse effects associated with the Jatenzo clinical trial included an increase in the red blood cells, headaches, nausea, high cholesterol and blood pressure and a decrease in the level of LDL. The patients who follow this treatment should constantly monitor their red blood cell counts and measure the levels of cholesterol. Any patient with benign prostate hyperplasia should be careful about worsening conditions since Jatenzo may cause an increase in prostate specific antigen levels. A boxed warning has been issued along with the prescribing information for increase in the risk of heart attack, increase in blood pressure and in the risk of cardiovascular death and stroke. Since it is the second testosterone product that has boxed warning associated with it, the FDA is now ensuring that all testosterone product manufacturers conduct blood pressure post-marketing trials to see if they have an effect.

 

“Jatenzo’s oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who up until now have most commonly been treated with testosterone products that are applied to the skin or injected,” said Hylton V. Joffe, M.D, M.M.Sc., director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “But it’s important to emphasize that this drug should not, like other testosterone treatments, be used to treat older men with ‘age-related hypogonadism.’ The benefits of testosterone therapy, including Jatenzo, have not been established for this use, and Jatenzo’s effects on raising blood pressure can increase the risks of heart attack, stroke and cardiovascular death in this population.”

 

FDA announces the approval of Mayzent, to treat secondary progressive Multiple Sclerosis with active disease.


In another news concerning Multiple sclerosis, FDA recently announced the approval of Mayzent (siponimod), for the treatment of patients, primarily adults, with relapsing forms of multiple sclerosis [5]. These relapsing forms include, relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) with active disease and clinically isolated syndrome (CIS). The approval was given to Novartis. SPMS is characterized by irreversible and progressive neurological disability. Unless patients have pre-existing cardiac conditions, they do not require a first dose observation. Mayzent will be available in approximately a week in the US.

There are various different forms of multiple sclerosis which is a debilitating chronic condition of the central nervous system affecting more than 2 million people around the world. The most common form is RRMS with the others being primary progressive MS and SPMS.  The normal functions of optic nerves, spinal cord and brain are affected. SPMS is identified by a gradual deterioration of neurological functions with time and is an initial form of RRMS. There is a large scope for developing efficient treatment to delay the disability progression in SPMS with active disease. Mayzent is a specific sphingosine-1-phosphate receptor modulator. It functions by selectively binding to S1P1 and S1P5 receptors. It prevents the lymphocytes from leaving the lymph nodes and thus entering the central nervous system of those with multiple sclerosis. To prevent inflammation, Mayzent may enter the CNS and bind to S1P1 and S1P5 receptors of astrocytes and oligodendrocytes to prevent inflammation and to catalyze remyelination. This medication has been indicated for use in active secondary progressive disease (in adults) and in relapsing forms of MS including clinically isolated syndrome (CIS). Since most patients transition to SPMS from RRMS with time, an early treatment is necessary to reduce the speed of disability progression. The approval was based on data from a Phase III, double-blind, randomized, placebo-controlled study called EXPAND. Its aim was to compare the safety and efficacy of Mayzent when compared to placebo, in patients with SPMS. The patients included in the study were of a mean age of 48 years at the time of initiation, had MS for more than 16 years and 50 percent or more had a median Expanded Disability Status Scale of 6.0 and depended on walking aid. The three-month confirmed disability progression (CDP) was significantly reduced by Mayzent. There was a significant delay in the six-month CDP as well. There were favorable effects observed in cognition, brain volume loss or brain shrinkage and MRI disease activity. The adverse effects seen during the trial included hypertension, headache and increase in transaminase.

Multiple Sclerosis From Top to Bottom

From Visually.

 

“One of the most important aims of MS treatment is delaying disability progression and preserving cognition,” said Paul Hudson, Chief Executive Officer, Novartis Pharmaceuticals. “With Mayzent, SPMS patients with active disease will have access to the first effective oral therapy directed towards disease progression, even when MS transitions to a stage where deterioration is less dependent on the usual relapse activity. Mayzent is a testament to the Novartis mission to reimagine medicine. We are delighted that our ongoing commitment to stop MS has led to a much-awaited treatment for these patients in need.” “We are grateful that there is a new treatment option for adults with active secondary progressive MS,” said Bruce Bebo, PhD, Executive Vice President, Research, US National MS Society. “We are hopeful this approval will stimulate a conversation between patients and healthcare professionals about disability progression after relapsing remitting MS and its early management.”

 

FDA approves the use of Dovato, a complete dual drug regimen for the treatment of patients with HIV with no prior antiretroviral treatment history.


FDA recently announced the approval of a two-drug complete regimen, for the treatment of patients with HIV-1 infections and those who haven’t undergone any antiretroviral treatment and who do not have any known or suspected substitutions linked to resistance to any of the individual components of the approved Dovato (dolutegravir and lamivudine). It is the first FDA-approved drug of its kind that is fixed-dosed and used to treat those who have not received any treatment for HIV before. The approval was granted to ViiV Healthcare. In February this year, the Department of Health and Human Services announced a plan called, Ending the HIV epidemic: A Plan for America. It is an initiative to reduce and remove HIV infections in the US resulting in 75 percent reduction in the next 5 years and a 90 percent reduction in the next ten years. Thus, the approval of Dovato is a step in that direction.

HIV is an epidemic affecting more than 1.1 million people living in the US. Around 1 in 7 are ignorant about their infection. The aim of the treatment for such patients involve reduction of viral load in blood. They are thus prescribed medications which reduce viral load and prevent disease progression. Such patients who take their medications on a daily basis have lesser chance of transmitting HIV to an HIV-negative person. The approval of Dovato was based on two identical randomized, double-blind, clinical trial which was done to determine the safety and efficacy of a once-daily administration of Dovato. The combined effects of lamivudine and dolutegravir as a combination-dose regimen, in reducing the amount of HIV in the blood, was similar to another regimen including emtricitabine, tenofovir and dolutegravir. The primary endpoint was to see if for 48 weeks, the patient was able to maintain less than 50 copies/ml and was considered successful, if it did. The most common AE’s associated with the treatment includes nausea, insomnia, diarrhea, headache and fatigue. Since there are known neural tube defects associated with dolutegravir, patients have been advised not to use Dovato during the first trimester of pregnancy. A boxed warning has also been issued for patients with both hepatitis B and HIV who should undergo additional treatments. In some cases, such patients who are undergoing a treatment with Dovato, have developed hepatitis B variants associated with resistance to lamivudine. Such patients may develop severe liver issues, hence they should be monitored by health care professionals.

The global state of HIV/AIDS

From Visually.

 

“Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug,” said Debra Birnkrant, M.D., Director of the Division of Antiviral Products. “Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time.”

 

FDA approves Evenity to treat postmenopausal women with osteoporosis and a high risk of bone fracture.


FDA recently approved a treatment for osteoporosis in postmenopausal women with an increased risk of bone fracture. The approval for the medication Evenity (romosozumab-aqqg) was given to Amgen [7]. It is indicated to treat postmenopausal women who have a history of osteoporotic fractures or those who have not and are intolerant to the existing osteoporosis therapies.

Osteoporosis

From Visually.

 

Osteoporosis is a common disorder observed in women after menopause. It leads to weakening of bones making them brittle and more prone to breakage. Evenity is a monoclonal antibody that functions by increasing bone formation and blocking the effects of sclerostin. The usual prescribed dose of Evenity consists of two injections, one followed by the other and given once a month by a health care professional. After 12 doses of Evenity, bone forming function of the medication decreases slowly. The approval was based on two clinical trials determining the safety and efficacy off Evenity in a group of 11,000 or more women with postmenopausal osteoporosis. At the end of one year of the first trial it was observed that Evenity showed a significant decrease in the risk of vertebral fracture. It was reduced by 73 percent when compared to the effects of placebo. In the second year of the trial, the good results from the first year were maintained even when it was followed by another osteoporosis therapy (denosumab), when compared to the effects of the placebo. After the first year of the second trial, a significant decrease in the new vertebral fracture (by 50 percent) was observed even when Evenity was followed by one year of alendronate (an osteoporosis treatment). This was found to be more effective than two years of only alendronate treatment. There was a decrease in nonvertebral fractures as well when compared to the data from the treatment of alendronate alone. Evenity comes with boxed warning that mentions an increase in the risk of heart attack and cardiovascular deaths as seen from the alendronate trial, though not observed in the placebo trial. Patients who had a stroke or heart attack in the last one year were advised not to use Evenity and must only follow this regimen after proper monitoring and consultation with their respective health care professionals. Some of the common side effects associated with the treatment includes headache, joint pain and certain injection-site reactions.


“Today’s approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk,” said Hylton V. Joffe, M.D, M.M.Sc., director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products. “But Evenity may increase the risk of heart attack, stroke and cardiovascular death so it’s important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year.”

 

Regeneron and Alnylam announces collaboration to develop and commercialize RNAi therapeutics targeting CNS (Central Nervous System) and Ocular diseases.


Regeneron and the leading RNAi therapeutics company, Alnylam Pharmaceuticals Inc., recently announced their collaboration that intends to discover, develop and commercialize new RNAi therapies to treat ocular and CNS diseases. The collaboration shall also invest in targets in the liver [8]. Alnylam Pharmaceuticals in recent times, achieved success in demonstrating highly durable techniques to deliver RNAi therapeutics that targets gene silencing in the CNS and the eye. Regeneron’s VelociSuite technologies and research from their Genetics Center will also contribute to the collaboration. It is thus expected to be mutually beneficial, using the scientific technologies of the two companies.

Based on the agreement, Regeneron will pay $400 million upfront to Alnylam. The price of each share will be $90 thus leading to a total of $400 million of Alnylam equity. The number is based on the volume-weighted average price over the last fifteen-trading-day period. The RNAi therapeutics company will be eligible to receive an additional $200 million in the form of milestone payments. These milestone payments will be based on pre-defined criteria in the field of early clinical development for the CNS and eye programs. All the alliance and equity-related agreements have been based on customary closing conditions and clearances under the Hart-Scott Rodino Antitrust Improvements Act. According to the collaboration deal, the companies will carry out programs directed to 30 targets and will introduce many into clinical development during the initial five-year discovery time. This comes with an option to extend time. Each of these programs will be worth $2.5 million at initiation and an additional $2.5 million at lead candidate identification. Both will be provided by Regeneron to Alnylam, which could finally translate to $30 million in funding for annual discovery. The roles of the two company in the alliance have also been clearly defined. Regeneron will lead the commercialization and development aspect for the programs based on the eye diseases and Alnylam will be entitled to milestones and royalty payments from them. Alnylam will be exclusive with Regeneron when it comes to RNAi therapeutics for eye and CNS diseases. There will be a joint effort on the CNS programs. But the global commercialization and development responsibility will lie exclusively with the lead party. Candidate selection for the CNS programs will be done by both companies. Apart from the ocular and CNS diseases, this collaboration shall also target a number of RNAi therapeutic program for target genes expressed in the liver which can have an effect on various diseases throughout the body. The companies will continue to work on RNAi therapeutics for chronic liver disease nonalcoholic steatohepatitis (NASH) based on the genetics center’s findings. The collaboration shall focus on a program that evaluates anti-C5 antibody-siRNA combinations for C5 complement-mediated diseases. It will evaluate the efficacy of the combination of Alnylam’s cemdisiran (at phase 2 developmental stage) with Regeneron’s pozelimab (REGN3918, currently in Phase 1 developmental stage). The right for development of cemsidiran monotherapy will continue to be with Alnylam, whereas the combination developments will be led by Regeneron. Alnylam will be eligible for royalties obtained from the combination product sales and both the companies will have an equal share investment and potential future profits on the monotherapy program. In case of all the other liver programs, both companies will be eligible to alternate leadership and participate equally in future profits. Alnylam will have rights on all the other unpartnered liver-directed clinical and preclinical programs in the pipeline.

Global RNA Based Therapeutics Market

From Visually.

 

“This new industry-leading alliance is aimed at realizing what we believe to be a significant opportunity for RNAi therapeutics as potentially transformative medicines for ocular and CNS diseases. We are thrilled to collaborate with Regeneron, a like-minded science-based organization, to significantly accelerate our efforts to bring RNAi therapeutics to patients,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “Importantly, the alliance structure enables Alnylam to continue to build its industry-leading pipeline of RNAi therapeutics while retaining significant product rights. In addition, the near-term payments under this new agreement will strengthen Alnylam’s balance sheet with over $2 billion in pro forma cash upon closing of the transaction, supporting our global efforts to develop and commercialize multiple products as potentially breakthrough medicines and advance our profile toward sustainable profitability.” “At Regeneron we believe the best use of our resources is to invest in potentially game-changing science that will yield innovative medicines for patients with serious diseases. This collaboration couples proven and emerging RNAi technology, which holds important promise in many diseases, with Regeneron’s world-leading genetics research and target discovery engine,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “This collaboration enables us to reach targets inside the cell complementing our expertise in antibodies, which are ideal for extracellular targets and those on the cell surface. Through the RGC and our other research groups, we are already identifying additional targets that may be well-suited for RNAi-based drug development, particularly in the eye and CNS.”

 

Pfizer announces the securing of an exclusive option to acquire Vivet Therapeutics.


Pfizer recently acquired 15 percent equity interest in Vivet Therapeutics, a privately help gene therapy biotech company that uses gene therapy to discover treatments for inherited liver disorders, especially those with unmet medical needs [9]. Pfizer now has an exclusive option to acquire all the outstanding shares and will collaborate with Vivet on the development of VTX-801, a treatment for Wilson disease, exclusively belonging to Vivet.

 

All the terms of the agreement have not been disclosed. Based on the ones available, Pfizer has paid approximately $51 million upon signing and may pay up to $635.8 million including the option to exercise payment and subject to certain regulatory, clinical and commercial milestones. Following the release of certain data from the Phase I/II clinical trial for VTX-801, Pfizer will have the choice to exercise its option of 100 percent acquirement of Vivet. Monika Vnuk, M.D., VP, Worldwide Business Development, will join Vivet’s Board of Directors. The candidate investigational gene therapy in question here is Vivet’s VTX-801, used for treatment of Wilson diseases. Wilson diseases is a chronic liver genetic disorder caused by mutations in the gene encoding the ATP7B protein. Due to this mutation, there is a reduced ability of the liver and other tissues to regulate the levels of copper, leading to impaired copper transport and serious copper poisoning. It may lead to severe hepatic damage, neurological symptoms which may be fatal. Under serious conditions, the only treatment available is liver transplant. The present available therapies do not bring about significant relief and also have important side effects. VTX-801 is therefore thought to be an effective remedy for Wilson disease as it has already been granted Orphan Drug Designation by the FDA. Pfizer and Vivet intend to advance their research by making use of liver-directed AAV gene therapy for metabolic diseases. Other than this program, Vivet is also heavily invested in providing breakthrough therapy for progressive familial intrahepatic cholestasis (PFIC) for bile excretion defects and citrullinemia for defects on the urea cycle.

“The potential of VTX-801 ahs already been demonstrated in preclinical models and our partnership with Pfizer will help accelerate development of VTX-801 and expand our innovative technologies,” said Gloria Gonzalez-Aseguinolaza, Vivet Co-founder and Chief Scientific Officer. Jean-Phillippe Combal, Co-founder and CEO of Vivet said, “We welcome Pfizer as a shareholder and partner that can help us advance our efforts to develop therapies for patients burdened with inherited liver disorders. This investment demonstrated the clear value of Vivet’s innovative approaches to gene therapy.” Mikael Dolsten, Pfizer Chief Scientific Officer and President, Worldwide Research, Development, and Medical, said,” Pfizer strives to provide meaningful enhancements to the lives of patients with rare diseases. Our partnership with Vivet offers an important expansion of Pfizer’s commitment to collaborate with the scientific community and to accelerate our leading AAV-directed gene therapy portfolio.”

 

References:

  1. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634671.htm.
  2. https://www.cimzia.com/about-ucb.
  3. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634837.htm.
  4. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634585.htm.
  5. https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-mayzent-siponimod-first-oral-drug-treat-secondary-progressive-ms-active-disease.
  6. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635526.htm.
  7. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635653.htm.
  8. http://investors.alnylam.com/news-releases/news-release-details/alnylam-and-regeneron-announce-broad-collaboration-discover.
  9. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_secures_exclusive_option_to_acquire_gene_therapy_company_vivet_therapeutics.

About the Author:

Esha Sehanobish

She is presently a Postdoctoral research fellow at Albert Einstein college of medicine, NY and works on characterization of enzymes that could act as potential therapeutic targets against tuberculosis. She is an enzymologist with a doctoral degree from the University of Central Florida in 2016. She loves using her communication skills to raise awareness about the importance of science in general by using social media. When she is not doing “science”, she loves designing and painting as a way of expressing ones thoughts through graphics and color.

Editor and Blog Design:

Abhi Dey

Abhi graduated from the Molecular Biophysics Unit of IISc (Bangalore, India) in 2011. As a Biomedical Scientist, he has worked with all three life-forms in his 13-year research career, viz., particulate, unicellular and multicellular. Currently, he is a Lead Scientist at MicroCures Inc. (New York, NY). Previously, he served as an Assistant Scientist at Emory University (Atlanta, GA) studying mechanisms of tumor recurrence in kids with brain tumors. As a postdoctoral fellow, he was the recipient of two Young Investigator Awards from Alex Lemonade Stand Foundation (Philadelphia, PA) and Rockland Immunochemicals. His research has been funded by Northwestern Mutual Foundation (Milwaukee, WI), CURE Childhood Cancer Foundation (Atlanta, GA) and American Association for Cancer Research (AACR).  When he is not on the bench you will find him spending time with his family or exploring the world through traveling and blogging.

Image Sources: Wikipedia and Twitter

Cover image: “This colorized scanning electron micrograph shows the structure of osteocyte cells in the cortex of a mouse tibia bone. Osteocytes are the cells that form new bone. Imbedding the bone in resin, which was subsequently etched with perchloric acid, created this particular image by removing the entire mineral in the sample leaving a replica of the area. Therefore, what is observed is the resin that filled the spaces in the bone and the spaces inside the cells.” Kevin MacKenzie (2012) CIL:39056, Mus musculus, osteocyte. CIL. Dataset. https://doi.org/doi:10.7295/W9CIL39056 Source

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The contents of Club SciWri are the copyright of Ph.D. Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers, and entrepreneurs).

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